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EC number: 445-090-6 | CAS number: 5614-37-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 June 2001 - 02 July 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed in accordance with several official test guidelines including OCED, EC and US EPA, and in compliance with GLP; on this basis the study is considered reliable without restriction.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 445-090-6
- EC Name:
- -
- Cas Number:
- 5614-37-9
- Molecular formula:
- C6 H12 O
- IUPAC Name:
- Cyclopentyl methyl ether
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Analytical purity: 99.6%
- Lot/batch No.: 01529
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver homogenate derived from Aroclor 1254-induced rats (S-9 mix).
- Test concentrations with justification for top dose:
- Range-finding study: 5, 15, 50, 150, 500, 1500, and 5000 µg/plate (with and without metabolic activation)
Definitive study: 50, 150, 500, 1500, and 5000 µg/plate (with and without metabolic activation). - Vehicle / solvent:
- Solvent: Dimethylsulfoxide (DMSO)
Solubility of the test material was assesed in both DMSO and water; the test substance was found to be insoluble in water, but soluble in DMSO. For this reason, DMSO was selected as the solvent.
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Positive control for TA1535 and TA100 in the absence of S9 mix
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Positive control for TA1537 in the absence of S9 mix
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Positive control for TA98 in the absence of S9 mix
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
- Remarks:
- Positive control for WP2uvrA/pKM101 in the absence of S9 mix
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- Positive control for TA1535 and WP2uvrA/pKM101 in the presence of S9 mix
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- Positive control for TA1537, TA98 and TA100 in the presence of S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:in agar (plate incorporation)
DURATION
- Preincubation period: 30 minutes (main test only)
- Exposure duration: 72 hours
NUMBER OF REPLICATIONS: 3 Plates per concentration
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth (appearance of background bacterial lawn) - Evaluation criteria:
- Number of revertant colonies, relative to concurrent vehicle controls. A two-fold increase in the number of revertant colonies relative to the concurrent control group, with some evidence of a dose-relationship is considered significant.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Observations:
No signs of toxicity were observed towards the tester
strains in either mutation test.
The first (range-finding) test was a standard plate
incorporation assay; the second involved a pre-incubation
stage.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this bacterial reverse mutation assay, the substance showed no evidence of mutagenic activity in any of the strains tested, either in the presence or absence of metabolic activation.
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